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Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist
Trials ; 20(1): 729-735, dez., 2019. tab., graf.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1049617
Biblioteca responsável: BR79.1
Localização: BR79.1


A considerable amount of randomized controlled trials (RCTs) have been published on statins and/or fibrates for diabetic retinopathy, a clinical condition associated with high social and economic burden. Adherence to the CONSORT statement items is imperative to ensure transparency and reproducibility in clinical research. The aim of this study is to assess the reporting quality and the adherence to CONSORT of RCTs assessing statins and/or fibrates for diabetic retinopathy.


We conducted a critical appraisal study at Discipline of Evidence-based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp). A sensitive literature search was performed to identify all relevant RCTs, with no time or language limits. Two authors independently evaluated the reporting quality of the selected RCTs using the CONSORT statement as a standard.


Thirteen reports of RCTs were included in this study. The adherence of the reports to CONSORT items ranged from 24% to 68%. The median score was 11 (interquartile range (IQR) 8 to 13). When analyzed separately, the methods sections of the reports had a median of three items (IQR 2 to 4) judged adherent to the methods items of CONSORT (items 3 to 12). The most underreported items were those related to trial design, title and abstract, allocation concealment, implementation of the randomization sequence, and blinding. Other important items, such as the one related to the description of the inclusion criteria, also had low adherence.


The overall adherence to the CONSORT checklist items was poor, especially in the items related to the methods section. RCT reports on statins and/or fibrates for diabetic retinopathy must be optimized to avoid reporting biases and to improve transparency and reproducibility. (AU)





Texto completo: Disponível Coleções: Bases de dados nacionais / Brasil Base de dados: Sec. Est. Saúde SP / SESSP-IDPCPROD Assunto principal: Ensaios Clínicos como Assunto / Viés de Publicação / Inibidores de Hidroximetilglutaril-CoA Redutases / Retinopatia Diabética / Hipolipemiantes Tipo de estudo: Ensaio clínico controlado Idioma: Inglês Revista: Trials Ano de publicação: 2019 Tipo de documento: Artigo Instituição/País de afiliação: Instituto Dante Pazzanese de Cardiologia/BR / Oxford University/GB / Universidade Federal de São Paulo (Unifesp)/BR